FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer
Dose escalation of NERLYNX therapy demonstrated improved management and prevention of Grade 3 diarrhea
LOS ANGELES, Calif., July 1, 2021 – Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement to the U.S. Prescribing Information for NERLYNX® that incorporates the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL Trial and the new 133 count commercial NERLYNX SKU. The new 133 count SKU, i.e., a bottle containing a four-week supply of 133 tablets, is aligned with the use of NERLYNX dose escalation and designed to better support patient needs. Read complete news release HERE.
View Prescribing Information.
Epizyme Launches EZH2Now Testing Program with Quest Diagnostics for Relapsed or Refractory Follicular Lymphoma Patients
EZH2Now Testing Program is first of its kind to offer national single gene testing for EZH2
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today launched the EZH2Now Testing Program, an Epizyme initiative in collaboration with Quest Diagnostics (NYSE: DGX), the leading provider of diagnostic information services, to provide EZH2 mutation testing for patients with relapsed or refractory (R/R) follicular lymphoma (FL).
“Epizyme is focused on providing access to information that will help physicians and their patients evolve the treatment of relapsed or refractory follicular lymphoma,” said Vicki Vakiener, Chief Commercial Officer at Epizyme. “While EZH2 is known to be a driver of FL regardless of mutation status, access to testing for EZH2 is desirable for some providers. Even though Next Generation Sequencing is commercially available, a number of physicians desire a single gene test. To meet the needs of these providers, Epizyme is collaborating with Quest Diagnostics to improve access to single gene testing for relapsed or refractory follicular lymphoma patients.”
Read complete release here.
CoPay Accumulator Patient Resources
Educate your patients with resources like this CoPay Accumulator video along with our printable brochures that will provide valuable information to your patients as they manage the financial impact of copay accumulator programs.
NCODA’s Legislative & Policy Advisory Committee continues to push for increased awareness to help patience afford their medications with copay assistance. For more information on the LPAC Committee, click here.
Documents Available for Download and Print:
FOR IMMEDIATE RELEASE
June 29th 2021
STATEMENT FROM NCODA Legislative & Policy Advisory Committee
Contact: Kevin Scorsone | NCODA Legislative & Policy Liaison
Phone: (919) 903-2057
LOUISIANA SIGNS LAW TO PROHIBIT WHITE BAGGING
June has been filled with announcements and progress in the world of oncology at state legislatures throughout the United States.
The Governor of Louisiana recently signed legislation that would prohibit “white bagging”. The term “white bagging” relates to drugs that are delivered to an oncology practice from an insurance provider’s preferred pharmacy. This practice is another example of limiting patients timely access to their preferred medication and has increasingly caused concern to the safety and well-being of patients.
NCODA applauds the decision by the Louisiana state legislature and the Governor to prohibit “white bagging” throughout the state. This law will guarantee that health insurance companies cannot refuse to pay for drugs that have been prescribed by physicians to insured Louisiana patients. This is a momentous bill signing and marks the first of its kind in the U.S.
NCODA has featured discussions on “white and brown bagging” at our Fall Summit and Spring Forum and those conversations were focused on the pitfalls of the onerous practice of drugs being supplied by an outside entity to practices, including treatment delays, excessive waste, burdensome inventory management and other factors that disrupt patient care.
It is our hope that legislative victories such as this will start a chain reaction in other states that will continue to focus on improving patient outcomes, and put patients’ needs and well-being at the forefront of care.
NCODA will continue to update our membership with any additional details and progress made with this issue.
CONTACTS: Jacquie Ross, Investors (650) 358-1054 Mary Lynn Carver, Media (410) 443-1853
For Immediate Release
KITE ANNOUNCES YESCARTA® CAR T-CELL THERAPY IMPROVED EVENT-FREE SURVIVAL BY 60% OVER CHEMOTHERAPY PLUS STEM CELL TRANSPLANT IN SECONDLINE RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA
— Landmark ZUMA-7 Study was Initiated in 2017 as the First Randomized Clinical Trial to Test the Earlier Use of a CAR T-cell Therapy Against Standard of Care —
— Study Met the Primary and Key Secondary Endpoints of Event-Free Survival and Objective Response Rate, Demonstrating a Highly Statistically and Clinically Significant Improvement Compared to Standard of Care —
Santa Monica, Calif., – June 28, 2021 – Kite, a Gilead Company (Nasdaq: GILD), today announced top-line results from the primary analysis of ZUMA-7, a randomized Phase 3 global, multicenter study showing superiority of Yescarta® (axicabtagene ciloleucel) compared to standard of care (SOC) in second-line relapsed or refractory large B-cell lymphoma (LBCL). With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). The study also met the key secondary endpoint of objective response rate (ORR). The interim analysis of overall survival (OS) showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future. Read more HERE.